CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs, CMOs, and suppliers in COVID-19 projects featuring Catalent, Sterling Pharma, ABL, and Singota.
Chemicals/Chemical API Manufacturing
Sterling Begins Hydroxychloroquine Production in the UK
Sterling Pharma Solutions, a Dudley, UK-headquartered CDMO, has begun production of hydroxychloroquine (HCQ), a treatment currently under investigation for COVID-19. Sterling will be manufacturing the active pharmaceutical ingredient with the finished product being manufactured and supplied by Accord Healthcare, a provider of generic and specialty pharmaceuticals.
The UK’s current supply of HCQ is sourced from overseas, according to information from Sterling Pharma. Sterling says its partnership with Accord will establish a domestic supply in the UK of the product should the drug prove successful.
Sterling says it has already supported Accord with the purchase of over 50 metric tons of the key raw materials, which equates to roughly 60 million finished tablets of HCQ. As a result of the partnership, Accord expects to supply up to 50 million HCQ tablets per month and has already started production of HCQ from its manufacturing facility in Barnstable, UK.
Source: Sterling Pharma Solutions
Biologics Manufacturing
Themis, ABL Europe Partner for Mfg of COVID-19 Vaccine Candidate
Themis, a clinical-stage biopharmaceutical company focused on immunomodulation therapies for infectious diseases and cancer, and ABL Europe, a CDMO/CRO subsidiary of the French bioindustrial group, Institut Mérieux, have signed an agreement under which ABL will manufacture Themis’ vaccine candidate against COVID-19 in preparation for clinical trials. The vaccine is being developed using a proprietary measles virus vaccine platform technology, which is licensed exclusively to Themis by the Institut Pasteur, a Paris-based research institute.
Themis recently announced that it is collaborating with Institut Pasteur, the Center for Vaccine Research at the University of Pittsburgh, and the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private partnership, to develop a COVID-19 vaccine candidate. CEPI has invested an initial $4.9 million for its development. ABL has been chosen by Themis to manufacture in France clinical-trial supplies of its COVID-19 vaccine candidate. ABL has facilities in Illkirch (Strasbourg) and Lyon, France, as well as in Rockville, Maryland.
Themis says it uses the measles-vaccine vector backbone as a vehicle to deliver selected, incorporated protein antigens from SARS-CoV2, the virus that causes COVID-19, directly to macrophages and dendritic cells, which are antigen-presenting cells that can trigger a specific immune response to the viral antigen. The applicability of the technology platform allows for the insertion of multiple large recombinant antigens from different pathogens into the vector.
Source: Themis
Formulation Development-Drug Product Manufacturing
Catalent Enters Pact with Ennaid for COVID-19 Antiviral
Catalent has entered into an agreement with Ennaid Therapeutics, an Alpharetta, Georgia-based specialty pharmaceutical company, to develop an oral, antiviral treatment targeted at COVID-19.
Under the agreement, Catalent will develop a powder-in-capsule formulation of Ennaid’s ENU200 program, a patent-pending, repurposed oral antiviral drug. ENU200 was selected by Ennaid as a candidate to treat COVID-19 following a bioinformatic search for in silico identification of prior-approved chemical compounds blocking the coronavirus proteins, spike-S glycoprotein and a key coronavirus enzyme.
Catalent’s development site in San Diego will manufacture roller-compacted formulations of ENU200 within capsules for further investigation.
Source: Catalent
Singota, Noveome Enter Mfg Pact for Potential COVID-19 Treatment
Singota Solutions, a Bloomington, Indiana-based CDMO, and Noveome Biotherapeutics, a Pittsburgh, Pennsylvania-based clinical-stage biopharmaceutical company, have entered into an agreement for Singota to manufacture Noveome’s investigational therapeutic drug, ST266, a biologic being evaluated in clinical studies for its potential treatment of the severe inflammatory reaction known as cytokine release syndrome (CRS), observed in COVID-19 patients.
Singota will manufacture Noveome’s ST266 to be used for intravenous infusion in Phase I and II clinical trials. Singota will manufacture 30-mL vial fills of ST266 in June (June 2020). Noveome says this timeline helps in its accelerated efforts to treat patients in the clinic, which it says prepares the company to initiate trials should the US Food and Drug Administration approve its requested authorization to proceed with dosing.
Source: Singota Solutions and Noveome Biotherapeutics
Packaging
Catalent in Clinical Supply Services for COVID-19 Treatment
Catalent reports that Humanigen, a clinical-stage biopharmaceutical company, has dosed the first COVID-19 patient in its previously announced Phase III study for lenzilumab, Humanigen’s a granulocyte macrophage-colony stimulating factor monoclonal antibody.
Catalent is providing clinical-supply support to Humanigen and its partners from its Philadelphia, Pennsylvania facility.
Catalent’s 200,000 square-foot Philadelphia facility provides clinical supply services, including clinical-supply management, comparator sourcing, package engineering, primary packaging, secondary packaging, labeling, cold-chain distribution, clinical storage, and returns and destruction.
